HIPPA Covered Entities Get New Directive: “Omnibus” Final Rule Released by HHS

Late yesterday, Health and Human Services (HHS) released the long anticipated “final rule” for HIPPA covered entities. Aptly called the “omnibus” privacy and security rule, it is comprehensive. A quick review: The Privacy Rule provides federal protections for personal health information and gives patients an array of rights with respect to that information. At the same time, it is balanced in that it permits the disclosure of personal health information when needed for patient care and other important purposes. The Security Rule specifies a series of administrative, physical, and technical safeguards for covered entities to use to assure the confidentiality, integrity, and availability of electronic protected health information.

“This final rule is comprised of four final rules,” HHS explains in the document (PDF), “which have been combined to reduce the impact and number of times certain compliance activities need to be undertaken by the regulated entities.”

Here are those “four” that HHS refers to:

1. Final modifications to the HIPAA Privacy, Security, and Enforcement Rules mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and certain other modifications to improve the Rules, which were issued as a proposed rule on July 14, 2010. These modifications:

  • Make business associates of covered entities directly liable for compliance with certain of the HIPAA Privacy and Security Rules’ requirements.
  • Strengthen the limitations on the use and disclosure of protected health information for marketing and fundraising purposes, and prohibit the sale of protected health information without individual authorization.
  • Expand individuals’ rights to receive electronic copies of their health information and to restrict disclosures to a health plan concerning treatment for which the individual has paid out of pocket in full.
  • Require modifications to, and redistribution of, a covered entity’s notice of privacy practices.
  • Modify the individual authorization and other requirements to facilitate research and disclosure of child immunization proof to schools, and to enable access to decedent information by family members or others.
  • Adopt the additional HITECH Act enhancements to the Enforcement Rule not previously adopted in the October 30, 2009, interim final rule (referenced immediately below), such as the provisions addressing enforcement of noncompliance with the HIPAA Rules due to willful neglect.

2. Final rule adopting changes to the HIPAA Enforcement Rule to incorporate the increased and tiered civil money penalty structure provided by the HITECH Act, originally published as an interim final rule on October 30, 2009.

3. Final rule on Breach Notification for Unsecured Protected Health Information under the HITECH Act, which replaces the breach notification rule’s “harm” threshold with a more objective standard and supplants an interim final rule published on August 24, 2009.

4. Final rule modifying the HIPAA Privacy Rule as required by the Genetic Information Nondiscrimination Act (GINA) to prohibit most health plans from using or disclosing genetic information for underwriting purposes, which was published as a proposed rule on October 7, 2009.

“This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented,” said Leon Rodriguez, director of the Office for Civil Rights (OCR) at HHS, also in the news release (OCR is responsible for enforcement). “These changes not only greatly enhance a patient’s privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a healthcare provider or one of their business associates,” Rodriguez said.

—Tom Finn

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